The scientific goal of the Developmental Therapeutics (DT) program is to develop and evaluate novel therapeutic compounds for the treatment of cancer;this goal and DTs rapid growth was achieved in strong part to the significant expertise and expansion of the cancer center cores over the past 5 years.Through the establishment of close interactions between basic research laboratories, clinical scientists, the NCI, and the pharmaceutical industry, the most rapid development of new treatment modalities is being accomplished. Preclinical studies are conducted using novel model systems, pharmacology, and functional imaging so that the appropriate biomarkers and patient selection criteria may be incorporated into early clinical trials of targeted agents. The programmatic goals are to provide the infrastructure, including cores and clinics, to foster collaborations, in order to allow the scientific exploration of new treatment modalities. Additional recruitments are ongoing to expand the investigation of novel therapy approaches. Seminars, discussion groups, training, and courses are provided to the members. This program is organized into four major interdisciplinary research areas: Drug Discovery, Preclinical Development, Early Clinical Development, and Delivery, under the leadership of S. Gail Eckhardt, MD. Dr. Eckhardt has extensive experience in the development of novel agents and in five years has built an NCI/ U01-funded Phase I program with a national reputation. In addition, a planning grant for an AP4 (Academic Public Private Partnership) Center was awarded and the full grant will be submitted in the summer of 2005. The DT program consists of 59 (36 Full;23 Associate) faculty members with atotal of $9.1 million in annual total costs ($3.9 million from NCI alone). The Developmental Therapeutics Program members produced a total of 456 cancer-related publications from 2000 to present. Of these, 175 (38%) are interprogrammatic and inter-/intra-programmatic publications;117 (26%) are intra-programmatic and inter-/intraprogrammatic publications. The goals for the next five years involve substantial expansion of the faculty with recruitment into the areas of hematological malignancies and solid tumors. The preclinical imaging capabilities will be expanded to include DCE-MRI, NMR/MRS, and PET. In addition, there are plans to utilize the infrastructure and collaborations provided by the AP4 Center to build an Oncology Drug Development Center.